RECOVERY ANTISEPTIC SKIN PREP- chloroxylenol lotion

Recovery Antiseptic Skin Prep by

Drug Labeling and Warnings

Recovery Antiseptic Skin Prep by is a Otc medication manufactured, distributed, or labeled by PURKLENZ FORMULATIONS INC., HK Kolmar Canada, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Active ingredient: Chloroxylenol 3%

PURPOSE

Purpose: Antiseptic

INDICATIONS & USAGE

Uses: Antiseptic cleanser.

Decreases harmful bacteria or germs.

WARNINGS

WARNINGS: FOR EXTERNAL USE ONLY.

DO NOT INGEST.

When using this product: Do not use in

or near the eyes and mouth (oral mucosa). In

case of eye contact, flush eyes with water.

Do not use if: you are allergic or sensitive to any of the listed ingredients.

Stop use and ask doctor if: Irritation, rash, or other allergic reaction occurs.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Directions: Apply as needed and scrub thoroughly for at least 30 seconds. Rinse well and repeat. For best results, do not dilute.

Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F)

OTHER SAFETY INFORMATION

Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F)

INACTIVE INGREDIENT

Inactive ingredients: Water (aqua), Lauryl Glucoside, Propylene Glycol, Cocamidopropyl Betaine, PPG-2 Hydroxyethyl Cocamide, Xanthan Gum, Citric Acid, Tetrasodium EDTA, Bis-Diglyceryl Polyacyladipate-2

Principal Display Package Labeling

RECOVERY
ANTISEPTIC
SKIN PREP

VEGAN-FRIENDLY
FREE OF ALCOHOL, PARABENS,
FRAGRANCES & DYES

30 FL. OZ. (900 mL)

NDC: 49436-377-30

recoveryaftercare.com
@recoveryaftercare

Distributed by
Recovery Aftercare, Inc.
Hanover, MD 21076

Made in Canada
©Recovery Aftercare, Inc. 2020

res

INGREDIENTS AND APPEARANCE

RECOVERY ANTISEPTIC SKIN PREP 
chloroxylenol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49436-377
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49436-377-30	900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	10/26/2020

Labeler - PURKLENZ FORMULATIONS INC. (078444179)

Registrant - PURKLENZ FORMULATIONS INC. (078444179)

Establishment
Name	Address	ID/FEI	Business Operations
HK Kolmar Canada, Inc		243501959	manufacture(49436-377)